Cleared Traditional

GS-1300 ATRAUMATIC GRASPING FORCEP, CURVED, 10MM (K900958) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K900958 · Solos Endoscopy, Inc. · General & Plastic Surgery device
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Apr 1990
Decision
50d
Days
Class 1
Risk

K900958 is an FDA 510(k) clearance for the GS-1300 ATRAUMATIC GRASPING FORCEP, CURVED, 10MM. Classified as Carrier, Ligature (product code GEJ), Class I - General Controls.

Submitted by Solos Endoscopy, Inc. (Norcross, US). The FDA issued a Cleared decision on April 18, 1990 after a review of 50 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Solos Endoscopy, Inc. devices

Submission Details

510(k) Number K900958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1990
Decision Date April 18, 1990
Days to Decision 50 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 115d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEJ Carrier, Ligature
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.